A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

NCT07007637 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 2 other identifiers: M1095-HS-303VELA-OLE
• Study Type: interventional
• Target: 835
• Locations: 16 countries
• Sites: 160

Brief Summary

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Suppuration; Anti-Inflammatory Agents; Sonelokimab; Nanobody; Apocrine Gland Disease

Outcome Measures

Primary Outcomes (6)

• Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab

  Incidence, relatedness, severity and seriousness of all AEs

  2.5-3 years

• Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)

  Incidence, relatedness, severity and seriousness of all TEAEs

  2.5-3 years

• Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)

  Incidence, relatedness, severity and seriousness of all AESIs

  2.5-3 years

• Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs

  Number of participants discontinued from sonelokimab treatment due to AEs

  2.5-3 years

• Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters

  Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline

  2.5-3 years

• Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram

  Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline

  2.5-3 years

Secondary Outcomes (6)

• Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

  2.5 - 3 years

• Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)

  2.5 - 3 years

• Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)

  2.5 - 3 years

• Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules

  2.5 - 3 years

• Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)

  2.5 - 3 years

Study Arms (1)

Experimental: sonelokimab

EXPERIMENTAL

All participants will receive sonelokimab 120 mg Q4W for up to 2 years

Drug: Sonelokimab

Interventions

Sonelokimab DRUG

Sonelokimab

Experimental: sonelokimab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
• Female participants are eligible to participate if they are not pregnant or breastfeeding
• Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.

You may not qualify if:

• Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
• Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
• Participants who plan to participate in another interventional study for a drug or device during this study.

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (160)

Clinical Site

Birmingham, Alabama, 35244, United States

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North Little Rock, Arkansas, 72117, United States

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Los Angeles, California, 90404, United States

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Northridge, California, 91325, United States

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Aventura, Florida, 33180, United States

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Coral Gables, Florida, 33134, United States

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Hialeah, Florida, 33012, United States

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Hollywood, Florida, 33021-6746, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33163, United States

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Ocala, Florida, 34471, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33613, United States

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Macon, Georgia, 31217, United States

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Sandy Springs, Georgia, 30328, United States

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Skokie, Illinois, 60077, United States

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West Dundee, Illinois, 60118, United States

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Columbus, Indiana, 47201, United States

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New Albany, Indiana, 47150, United States

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Plainfield, Indiana, 46168, United States

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Louisville, Kentucky, 40241, United States

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Murray, Kentucky, 42071, United States

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Metairie, Louisiana, 70006, United States

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Boston, Massachusetts, 02116, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109-5314, United States

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Canton, Michigan, 48187, United States

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Clarkston, Michigan, 48346, United States

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Waterford, Michigan, 48328, United States

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New Brighton, Minnesota, 55112, United States

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Omaha, Nebraska, 68144, United States

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Las Vegas, Nevada, 89148, United States

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New York, New York, 10003, United States

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New York, New York, 10012, United States

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The Bronx, New York, 10467, United States

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Fargo, North Dakota, 58103, United States

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Boardman, Ohio, 44512, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45324, United States

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Oklahoma City, Oklahoma, 73118, United States

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Murfreesboro, Tennessee, 37130, United States

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Dallas, Texas, 75235, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77004, United States

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San Antonio, Texas, 78213, United States

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San Antonio, Texas, 78218, United States

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South Jordan, Utah, 84095, United States

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Mill Creek, Washington, 98012, United States

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Morgantown, West Virginia, 26505, United States

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Pleven, Ontario, 5800, Bulgaria

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Sofia, Ontario, 1463, Bulgaria

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Stara Zagora, Ontario, 6003, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1510, Bulgaria

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Sofia, 1606, Bulgaria

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Calgary, Alberta, T3E 0B2, Canada

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Edmonton, Alberta, T6G 1C3, Canada

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Edmonton, Alberta, T6H 4J8, Canada

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Sherwood Park, Alberta, T8H 0P1, Canada

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Winnipeg, Manitoba, R3M 3Z4, Canada

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Fredericton, New Brunswick, E3B 1G9, Canada

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Barrie, Ontario, L4M 7G1, Canada

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Guelph, Ontario, N0B 2J0, Canada

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London, Ontario, N6H 5L5, Canada

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Markham, Ontario, L3P 1X3, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Peterborough, Ontario, K9J 5K2, Canada

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Toronto, Ontario, M2N 3A6, Canada

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Toronto, Ontario, M4E 1R7, Canada

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Toronto, Ontario, M5A3R6, Canada

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Montreal, Quebec, H1Y 3L1, Canada

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Québec, Quebec, G1W 4R4, Canada

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Saskatoon, Saskatchewan, S7K 2C1, Canada

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Ostrava, 708 52, Czechia

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Prague, 110 00, Czechia

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Brest, 29200, France

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Lyon, 69003, France

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Saint-Mandé, 94160, France

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Saint-Priest-en-Jarez, 42270, France

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Halle, Saale, 06108, Germany

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Bad Bentheim, 48455, Germany

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Berlin, 10117, Germany

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Berlin, 10789, Germany

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Bielefeld, 33647, Germany

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Bochum, 44791, Germany

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Bochum, 44793, Germany

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Bramsche, 49565, Germany

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Darmstadt, 64283, Germany

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Dresden, 01307, Germany

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Erlangen, 91054, Germany

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Frankfurt, 60590, Germany

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Hanover, 30159, Germany

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Kiel, 24105, Germany

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Langenau, 89129, Germany

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Lübeck, 23538, Germany

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Mahlow, 15831, Germany

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Münster, 48149, Germany

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Wuppertal, 42283, Germany

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Würzburg, 97080, Germany

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Debrecen, 4026, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7632, Hungary

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Chieti, 66013, Italy

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Cona, 44124, Italy

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Milan, 20122, Italy

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Modena, 41126, Italy

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Perugia, 06129, Italy

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Pisa, 56126, Italy

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Roma, 00168, Italy

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Rozzano, 20089, Italy

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Torino, 10126, Italy

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Torrette, 60126, Italy

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Rotterdam, 3015 GD, Netherlands

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Oslo, 0424, Norway

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Bialystok, 15-453, Poland

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Chorzów, 41-516, Poland

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Gdansk, 80-214, Poland

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Katowice, 40-611, Poland

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Kielce, 25-316, Poland

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Krakow, 30-002, Poland

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Krakow, 30-727, Poland

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Lodz, 90-265, Poland

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Lodz, 90-436, Poland

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Lublin, 20-573, Poland

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Ossy, 42-624, Poland

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Poznan, 60-539, Poland

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Poznan, 60-848, Poland

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Sosnowiec, 41-200, Poland

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Szczecin, 70-332, Poland

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Szczecin, 71-270, Poland

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Warsaw, 00-710, Poland

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Warsaw, 02-507, Poland

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Warsaw, 02-692, Poland

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Warsaw, 02-953, Poland

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Wroclaw, 50566, Poland

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Wroclaw, 51-503, Poland

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Lisbon, 1169-050, Portugal

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Lisbon, 1649-035, Portugal

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Trnava, 91775, Slovakia

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Alicante, 03010, Spain

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Badalona, 08916, Spain

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Barcelona, 08003, Spain

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Cadiz, 11009, Spain

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Córdoba, 14004, Spain

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Granada, 18012, Spain

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Granada, 18014, Spain

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Granollers, 08402, Spain

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Madrid, 28006, Spain

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Madrid, 28041, Spain

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Madrid, 28046, Spain

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Manises, 46940, Spain

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Málaga, 29010, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 41009, Spain

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Valencia, 46014, Spain

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Valencia, 46026, Spain

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Salford, M6 8HD, United Kingdom

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MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Suppuration

Interventions

sonelokimab

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 13, 2028
• Study Completion (Estimated): June 13, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

CZ (2); PT (2); GB (1); NL (1); US (49); CA (18); SL (1); FR (4); DE (20); IT (10); BE (2); BU (7); ES (17); PL (22); NO (1); HU (3)